Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines hold promise to control the pandemic and help restore normal social and economic life, even as variant threats loom.  Since December 2020, the U.S. Food and Drug Administration (“FDA”) has issued three emergency use authorizations (“EUA”) for vaccines having demonstrated a high efficacy of preventing COVID-19 caused by SARS-CoV-2, with more vaccines in various stages of testing¹.  The Centers for Disease Control and Prevention (“CDC”) claims there is a growing body of evidence suggesting fully vaccinated people are less likely to have symptomatic infection or transmit the virus to others².  However, as seen in new clusters of infection around the country, even highly effective vaccines cannot curb the pandemic without high population vaccine coverage and maintenance of other mitigation strategies.  Amid the COVID-19 vaccine rollout, U.S. hospitals, health systems, and medical staffs are actively developing strategies and policies aimed at minimizing the spread of COVID-19 to protect their patients, visitors, employees, and staff.  This issue is likely to become more prominent over time, especially if any of the EUA vaccines are fully approved by the FDA or the need to vaccinate a large share of the U.S. population becomes urgent in the face of threatening variants, even as some individuals continue to show reluctance to vaccination.  This article examines the nature of vaccination mandates in hospitals and the underlying legal issues surrounding this topic.

Legal Considerations for Vaccination Policies

History of Hospitals and Health Systems Routinely Requiring Vaccination of Medical Staff Members

The constitutionality of immunization requirements was first addressed by the Supreme Court of the United States in 1905.  In 1902, a vaccination mandate was issued in certain locations in Massachusetts, in response to a smallpox outbreak.  In Jacobson v. Massachusetts, the state allowed cities to enforce mandatory, free vaccinations for adults if the municipality determined it was necessary for the public health or safety of the community; those who refused the vaccines were subject to a fine.  The Court considered whether a state’s broad authority to regulate individual rights to protect the general health, safety, morals, and welfare of society as a whole, extended to mandatory vaccinations.  Ultimately, the Court held that mandatory vaccination is justified by the necessity to protect public health and welfare³.

The Jacobson decision led to the implementation of school entry requirements for immunization.  School entry rules have shown tremendous success in reducing the incidence of vaccine-preventable diseases among children in the United States⁴.  Courts have consistently upheld the constitutionality of immunization as an entry requirement⁵.  The success of those school entry rules laid the groundwork for hospitals and health systems to establish influenza vaccine requirements for healthcare workers.  

Public health officials frame the issue of vaccine mandates for health care professionals as one of patient safety.  According to the American Journal of Preventative Medicine (“AJPM”), “the literature shows that outbreaks of influenza in healthcare facilities are a significant source of patient illness and death, and that vaccination of healthcare professionals can reduce patient death rates in these facilities by preventing transmission of influenza from healthcare workers to patients.”⁶  A number of professional societies, including the Advisory Committee on Immunization Practices (“ACIP”), recommends influenza vaccination for all healthcare professionals to reduce transmission to vulnerable patients⁷.  As such, institutions have increasingly adopted influenza vaccination mandates, employing multiple disciplinary steps up to and including termination of unvaccinated health care workers without medical contraindications or religious objections⁸.  However, healthcare professionals have had mixed responses to such mandates.  According to the AJPM, “a substantial majority of healthcare professionals reported . . . that an influenza vaccine mandate was important for protecting patients (96.7%) and employees (96.4%), and 89.6% said that a mandate was an important professional ethical responsibility. Despite this, 72.0% thought an influenza vaccine mandate was coercive, and 17.7% thought it violated their contract.”⁹

Regardless of the mixed feelings among healthcare providers about influenza vaccination mandates, the efficacy of the influenza vaccine has resulted in a multitude of immunizations becoming common entry requirements for healthcare professionals to limit their risk of exposure to vaccine-preventable diseases.  While those requirements vary among institutions, the CDC recommends that healthcare professionals stay-up-to date with the following vaccines:  Hepatitis B, Influenza, MMR (Measles, Mumps, and Rubella), Varicella, and TDP (Tetanus, Diphtheria, and Pertussis)¹⁰.  As with school entry requirements, legal challenges to immunization entry requirements for healthcare professionals have been unsuccessful¹¹.   

Federal Government’s Power to Mandate Vaccinations

At present, the federal government’s authority to institute a general vaccine mandate has not been tested in the courts.  The Commerce Clause of the U.S. Constitution grants Congress the power to regulate commerce between states as well as with foreign countries¹².  Drawing on this authority, the Public Health Service Act (“PHSA”) authorizes the U.S. Health and Human Services’ Secretary—who, in turn, may delegate this authority to the CDC and FDA—to adopt quarantine and isolation measures to prevent the spread of communicable disease among states¹³.  However, this authorization does not specifically mention federal vaccine mandates.   In the absence of a federal mandate, employers must rely on guidance from a variety of federal and state organizations when considering their own vaccination policies.  For example, California’s Department of Fair Employment and Housing has taken the position that employers may require employees to receive an FDA-approved vaccination against COVID-19 so long as the employer does not discriminate or harass employees or job applicants on the basis of a protected class¹⁴

Equal Employment Opportunity Commission Guidance

In December 2020, the Equal Employment Opportunity Commission (“EEOC”), in response to the EUAs granted by the FDA, published guidance outlining employer compliance mandates under the Americans with Disabilities Act (“ADA”), Title VII of the 1964 Civil Rights Act (“Title VII”) and the Genetic Information Nondiscrimination Act (“GINA”).  Overall, this guidance suggests employers may mandate COVID-19 vaccinations so long as their policies retain reasonable accommodations for those with medical conditions and sincerely held religious beliefs. 

Occupational Safety and Health Administration Guidance

On May 21, 2021, the Occupational Safety and Health Administration (“OSHA”) updated its guidance to clarify the recordability of adverse side effects suffered by employees due to a COVID-19 vaccination¹⁵.  Per the new guidance, “OSHA does not want to give any suggestion of discouraging workers from receiving COVID-19 vaccination or to disincentivize employers’ vaccination efforts. As a result, OSHA will not enforce 29 CFR 1904’s recording requirements to require any employers to record worker side effects from COVID-19 vaccination through May 2022.”¹⁶ This guidance is likely a welcome relief to employers considering mandatory vaccination policies because it ensures that employees’ adverse reactions are not registered on a company’s OSHA recordkeeping logs through May 2022.  By avoiding those recordkeeping requirements with OSHA, a mandatory COVID-19 vaccination policy presents minimal risk of negatively affecting employers’ insurance rates or, in some industries, their ability to bid for work. 

State Action

A number of states have proposed bills that would have the effect of prohibiting employers from mandating COVID-19 vaccinations prior to full approval by the FDA.  These states currently include: Alabama, Arizona, Connecticut, Illinois, Iowa, Kansas, Kentucky, Maryland, Minnesota, New York, Oklahoma, Pennsylvania, Rhode Island, South Carolina, South Dakota, Texas, and Washington¹⁷.  At this time, none of these bills have been enacted as law.  In contrast, New York has also introduced a bill that would require vaccination if the state fails to achieve herd immunity¹⁸.  Texas recently passed SB 968, a bill which prohibits businesses from requiring customers to provide documentation of vaccination¹⁹.  While no such bill has been passed for employees, customer vaccination prohibitions—commonly referred to as vaccine passport prohibitions—could be a precursor for employee vaccination prohibitions in these states.  As such, these bills highlight the need for hospitals and health systems to carefully review state and local laws prior to enacting vaccination policies—including a vaccination mandate.  

Do Physicians Have A Responsibility To Be Vaccinated?

Aside from hospitals mandating their employees be vaccinated, physicians may have an ethical responsibility to be vaccinated.  According to the American Medical Association’s (“AMA”) Code of Ethics, physicians are ethically obligated to accept the COVID-19 vaccination.  Per Opinion 8.7—Routine Universal Immunization of Physicians—when a safe effective vaccine is available, physicians have a responsibility to accept immunization in the interest of protecting their patients, their colleagues, and the community²⁰.  Additionally, Opinion 8.4—Ethical Use of Quarantine and Isolation—holds that vaccination is a part of a physician’s overall responsibility in responding to public health crises²¹. 

This ethical responsibility is not absolute.  The AMA’s Council on Ethical and Judicial Affairs has adopted the position that a physician must determine how readily transmissible the disease is and weigh the risks to patients with whom the physician is in contact with relative to the risks of immunization to the physician²².  The greater the risk to the patient, the stronger the ethical obligation for a physician to be immunized.

In addition to the AMA, a number of professional societies recommend mandatory vaccination policies for healthcare professionals. 

Recent Actions by U.S. Hospitals and Health Systems

Houston Methodist Hospital (“Houston Methodist”), which comprises an academic medical center and six community hospitals in Texas, implemented a policy on March 31, 2021, requiring all 26,000 employees, including residents and fellows, to be vaccinated against COVID-19²³.  Houston Methodist allowed employees until June 7, 2021 to comply with this policy²⁴.  All non-compliant employees without an approved exception were subject to suspension and eventual termination²⁵.  On June 7, 2021, Houston Methodist suspended 178 workers without pay for failing to meet the vaccination deadline²⁶.  Those employees had until June 21, 2021 to be vaccinated, or face being fired.  Notably, the hospital granted exemptions or deferrals to this vaccine requirement for medical contraindications (including pregnancy) and sincerely held religious beliefs for nearly 600 employees²⁷.

The policy was met with resistance. On May 28, 2021, 117 Houston Methodist employees filed a lawsuit against the hospital, requesting the court block the hospital from enforcing the policy.  The lawsuit alleged the employees’ refusal to comply would equate to wrongful termination under various public policy causes of action. Central to the lawsuit, the employees argued that the mandatory vaccination policy amounted to unlawful coercion (i.e., the threat of termination) for refusal to take what the employees referred to as an “experimental” vaccine²⁸.  In support of this argument, the employees cited to the emergency use status and lack of full approval by the FDA of the vaccines currently available²⁹.  

Mere weeks later, on June 12, 2021, a federal judge dismissed the lawsuit and concluded there was nothing illegal or against public policy about receiving the COVID-19 vaccine.  While the court stressed that vaccine safety and efficacy were not considered in adjudicating this case, it also acknowledged that the employer’s mandatory vaccination policy would, in its judgment, provide a safer work environment for employees and patients. Importantly, the court also emphasized that a private employer’s mandatory vaccination policy does not amount to coercion: “[an employee] can freely choose to accept or refuse a COVID-19 vaccine; however if she refuses, she will simply need to work somewhere else.”³⁰  The employees have appealed the court’s ruling, which is pending, and The Associated Press has reported that 153 Houston Methodist workers have since resigned or been fired for failure to meet the vaccination deadline³¹.

While this case serves as an important bellwether, its application could be limited—particularly in other states that provide for more expansive public policy claims. The claim chiefly relied on by the Texas plaintiffs is extremely narrow in application and generally only applies in instances where an employee is terminated for the refusal to perform an illegal act that carries criminal penalties. In short, while the legal analysis could differ in other states, employers can now cite at least one legal opinion that has endorsed the use of mandatory vaccination policies. 

A number of other hospitals and health systems including, but not limited to, SSM Health, New York-Presbyterian, RWJBarnabas Health, Johns Hopkins Medicine, The University of Maryland Medical System, University of Pennsylvania Health System, Henry Ford Health System and Indiana University Health, have joined Houston Methodist in announcing similar vaccination mandates for their employees.  We anticipate this list will continue to grow in the coming months and expect additional legal challenges to those policies.  These anticipated challenges will likely be state-specific and hinge on the worker laws that are applicable in each such forum.

Recommendations

Vaccination policy in light of COVID-19 is a rapidly evolving topic in the United States.  Any plans for medical staff workforce vaccination must be sensitive to those changes.  Vaccination programs should be tapered to the specific needs of the hospital or health system’s medical staff members, employees, patients, and operations.  As such, it is unlikely that a single vaccination policy will be appropriate for all hospitals and health systems.  Taken in combination with the complex interactions between federal and state law, hospitals and health systems should carefully consider any potential policies and programs mandating vaccination in consultation with counsel. 

FOOTNOTES

 ¹FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine, U.S. FOOD AND DRUG ADMINISTRATION (Dec. 11, 2020)

 ²Science Brief: COVID-19 Vaccines and Vaccination, CENTERS FOR DISEASE CONTORL AND PREVENTION (last updated May 27, 2021)

³  Jacobson v. Commonwealth of Massachusetts, 197 U.S. 11, 25 S. Ct. 358, 49 L. Ed. 643 (1905).

⁴ Megan C. Lindley, MPH, et al., Assessing State Immunization Requirements for Healthcare Workers and Patients, AMERICAN JOURNAL OF PREVENTIVE MEDICINE 32(6) (2007). 

⁵ See Phillips v. City of New York, 775 F.3d 538 (2d Cir. 2015) (Court found that New York’s vaccination requirement for public school students does not violate the free exercise of religion); Workman v. Mingo Cty. Bd. of Educ., 419 F. App’x 348 (4th Cir. 2011) (Court found that a parent did not have fundamental substantive due process rights to refuse to have her child immunized in accordance to West Virginia’s vaccination requirements for public school students).

⁶ See Megan C. Lindley, supra note 4 at 459. 

⁷ Lisa A. Grohskopf, MD, et al., Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices — United States, 2020–21 Influenza Season, ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES 69(8): 1-24 (Aug. 21, 2020).

⁸ Marci Drees, MD, MS, et al., Carrots and Sticks: Achieving High Healthcare Personnel Influenza Vaccination Rates without a Mandate, INFECTION CONTROL & HOSPITAL EPIDEMIOLOGY 36(6): 717 (2015). 

⁹ Samantha I. Pitts, MD, MPH, et al., A Systematic Review of Mandatory Influenza Vaccination in Healthcare Personnel, AMERICAN JOURNAL OF PREVENTIVE MEDICINE 47(3): 337 (2014). 

¹⁰ Recommended Vaccines for Healthcare Workers, CENTERS FOR DISEASE CONTORL AND PREVENTION (last reviewed May 2, 2016)

¹¹ Fallon v. Mercy Cath. Med. Ctr. of Se. Pennsylvania, 877 F.3d 487, 490 (3d Cir. 2017);  (A hospital employee brought action against a hospital following his termination for failure to comply with the hospital’s vaccination policy, alleging religious discrimination under Title VII of the Civil Rights Act of 1964. The Court rejected the employee's beliefs supporting his refusal to receive flu vaccination were not protected religious beliefs under Title VII.); Brown v. Children’s Hosp. of Philadelphia, 794 F. App’x 226, 227 (3d Cir. 2020) (to state a claim under Title VII of the Civil Rights Act of 1964, “it is not sufficient merely to hold a sincere opposition to vaccination; rather, the [hospital employee] must show that the opposition to vaccination is a religious belief. . .in assessing whether beliefs are religious, we consider whether they ‘address fundamental and ultimate questions having to do with deep and imponderable matters,’ are ‘comprehensive in nature,’ and are accompanied by ‘certain formal and external signs.’” (quoting Africa v. Pennsylvania, 662 F.2d 1025, 1032 (3d Cir. 1981)).

¹² U.S. Const. art. I, § 8, cl. 3. 

¹³ Public Health Service Act, Pub. L. No. 104-321; Codified at 42 U.S.C. § 247d.

¹⁴ FAQ: DFEH Employment Information on COVID-19, CA DEPARTMENT OF FAIR EMPLOYMENT AND HOUSING (Mar. 4, 2021)

¹⁵ Protecting Workers: Guidance on Mitigating and Preventing the Spread of COVID-19 in the Workplace, OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION (last updated Jun. 10, 2021)

¹⁶ Id

¹⁷ H.B. 214, Reg. Sess. (Al. 2021), S.B. 1648, 55th Leg., 1st Reg. Sess. (Az. 2021), H.B. 5402, Gen. Assemb., Jan. Sess. (Ct. 2021), H.B. 3682, 102nd Gen. Assemb., Reg. Sess. (Il. 2021), S.F. 193, 89th Gen. Assemb., 2021 Sess. (Ia. 2021), S.B. 213, 2021 Sess. (Ks. 2021), S.B. 98, Gen. Assemb., 2021 Reg. Sess. (Ky. 2021), H.B. 1171, 442nd Gen. Assemb. (Md. 2021), H.F. 2511, 92nd Leg. (Mn. 2021), S.B. 408, 55th Leg., 1st Sess. (NM. 2021), A.B. A04602, Reg. Sess. (NY. 2021), S.B. 765, 58th Leg., 1st Sess. (Ok. 2021), H.B. 262, Gen. Assemb., Reg. Sess. (Pa. 2021), H.B. 5989, Gen. Assemb., Jan. Sess. (RI 2021), H.B. 3511, Gen. Assemb., 124th Sess. (SC 2021), H.B. 1159, 96th Leg., Sess. 663 (SD 2021), H.B. 1687, 87th Leg., Reg. Sess. (Tx. 2021), H.B. 1305, 67th Leg., Reg. Sess. (Wa. 2021). 

¹⁸ A.B. A11179, Reg. Sess. (NY 2020). 

¹⁹ S.B. 968, 87th Leg., Reg. Sess. (Tx. 2021).

²⁰ Routine Universal Immunization of Physicians, AMERICAN MEDICAL ASSOCIATION (last visited Jul. 9, 2021) 

²¹ Ethical Use of Quarantine & Isolation, AMERICAN MEDICAL ASSOCIATION (last visited Jul. 9, 2021)

²² Report: Amendment to Opinion 8.7, “Routine Universal Immunization of Physicians”, AMERICAN MEDICAL ASSOCIATION, COUNCIL ON ETHICAL AND JUDICIAL AFFAIRS (Nov. 2, 2020)

²³ COVID-19 Vaccine Requirement FAQ, HOUSTON METHODIST HOSPITAL (last visited Jul. 9, 2021)

²⁴ Id

²⁵Mandatory COVID-19 Vaccine Procedure – Phased Implementation, HOUSTON METHODIST HOSPITAL (last reviewed Apr. 15, 2021)

²⁶ Bill Chappell, The Clock's Ticking for 178 Hospital Workers Suspended for Not Getting Vaccinated, NPR (Jun. 10, 2021)

²⁷ Id

²⁸ Jennifer Bridges, et al., v. The Methodist Hospital et al., 2021 WL 2221293, No. 4:21-cv-01774 (S.D. Tex. 2021).

²⁹ Id

³⁰ Id

³¹ Jamie Stengle, Houston Hospital Workers Fired, Resign Over COVID-19 Vaccine, THE ASSOCIATED PRESS (Jun. 22, 2021)